Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Galaxy ACIF cage H5 x W16 x L14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396101 ()

  • Height: 5 Millimeter
  • Width 16mm, Length 14mm
NC551614

  • Bone-screw internal spinal fixation system, non-sterile
Galaxy ACIF cage H5 x W15 x L14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396057 ()

  • Width 15mm, Length 14mm
  • Height: 5 Millimeter
NC551514

  • Bone-screw internal spinal fixation system, non-sterile
Galaxy ACIF cage H5 x W14 x L12
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396002 ()

  • Height: 5 Millimeter
  • Width 14mm, Length 12mm
NC551412

  • Bone-screw internal spinal fixation system, non-sterile
TRIAL L12 x W14 x A7 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809489299392 ()
AC.2025

  • Bone-screw internal spinal fixation system, non-sterile
TRIAL L14 x W16 x A7 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809489299149 ()
AC.2041

  • Bone-screw internal spinal fixation system, non-sterile
ACIF Depth Stop Trial, MD, 12°, H5/H6mm
CTL Medical Corporation
113.7475
In Commercial Distribution

  • 00841732165168 ()


  • Metallic spinal interbody fusion cage
ACIF Depth Stop Trial, SM, 12°, H5/H6mm
CTL Medical Corporation
113.7465
In Commercial Distribution

  • 00841732165137 ()


  • Metallic spinal interbody fusion cage
Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder
Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder
TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006432 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
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